Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- 10ACR Urine Strip Leukocytes Nitrite Blood pH Creatinine Specific Gravity Ketones Microalbumin Protein Glucose For Urine FDA UDI
- Model / Reference
- UA10ACR FDA UDI
- Description
- 10ACR Urine Strip Leukocytes Nitrite Blood pH Creatinine Specific Gravity Ketones Microalbumin Protein Glucose For Urine FDA UDI
Identifiers
- Catalog Number
- UA10ACR FDA UDI
- Primary DI / UDI-DI
- 20885380175548 FDA UDI
- FDA Product Code
- JMT FDA UDIJIO FDA UDILJX FDA UDIJIR FDA UDIJRE FDA UDIJFY FDA UDIJIL FDA UDIKQO FDA UDIJIN FDA UDI
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1510 FDA UDI864.6550 FDA UDI864.7675 FDA UDI862.1645 FDA UDI862.2800 FDA UDI862.1225 FDA UDI862.1340 FDA UDI862.2900 FDA UDI862.1435 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Cardinal Health by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 2cf50bc1-1a74-41fe-954a-c3b2ac9f370d 35 fields · synced Jun 8, 2026